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| Nutraceuticals-Emerging Trends-Regulatory Perspective |
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| On March 17, 2001 at SciTech Center, organized by All India Drug Control Officers' Confederation (AIDCOC) and India Pharmaceutical Association (IPA). |
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| In Europe 50% of $ 5 billion food market is based around nutraceuticals and the global market is expected to grow to the extent of $ 3 trillion. These products popularly known as dietary supplements or nutraceuticals are increasingly being imported in India or manufactured locally. These products which are available mostly in the form of capsules, tablets, powders or granules are not claimed as medicines but are marketed and consumed for certain health claims or nutritional benefits. However, they do not fit into the category of conventional food under the regulatory framework of Prevention of Food Adulteration Act, 1954. |
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| In Ayurvedic principle, there is integration of food and medicines and therefore formulating food as health food has been well-accepted practice. But the same has not been accepted or reflected in both Prevention of Food Adulteration Act 1954 and the Drugs and Cosmetics Act 1940. The genetic engineering aspect of biotechnology has been increasingly recognized as the most effective technology to enhance the nutritional value of food. Confusion, however still exists on the international level as to proper classification of the new products evolving in this newly explored frontier of food technology. |
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| In India, the manufacture, sale and distribution of drugs is regulated under the Drugs and Cosmetics Act 1940. The quality and safety of food is regulated under the Prevention of Food Adulteration Act 1954. The provision of the Drugs and Cosmetics Act and Prevention of Food Adulteration Act , 1954 are adequate to regulate substances that are explicitly marketed with claims as drug or food . However, there is some ambiguity about the classification of the products that are popularly known as dietary supplements, nutraceutical health food, functional food or herbal supplements etc. Under the existing provisions of Drugs and Cosmetics Act, if medicinal claims are made in respect of such products , then the said products will have to be classified as drugs. |
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| These ambiguities pose many questions before industry, trade and the exporters for which clear answers are not forthcoming. The regulators also face a dilemma since the substances could have status as either a food or drug, depending on the claims made for the product. Many botanical herbs used in manufacturing of these products may have been in use in one or another country for certain health claims. Against this background the basic issues such as quality, safety, labeling and classification of these products need focused consideration. The need was to have clarity on the subject in the context of the regulatory environmental prevailing in the country. |
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| Speakers |
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| R.W. Gudal |
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| Joint Commissioner - H.Q. & Controlling Authority, F.D.A., |
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| Maharashtra. |
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| Swati Piramal |
| Chief Scientific Officer - Nicholas Piramal Ltd., Mumbai. |
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| J.P. Parswani |
| General Manager, marketing and Sales - E.Merck India Ltd. |
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| Narendra Bhat |
| President and C.E.O. - Bio Ved Pharmaceuticals Pvt. Ltd., Pune. |
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